Harriet G Rosenberg

Should people at low risk of cardiovascular disease take a statin

A review of statins for primary prevention of cardiovascular disease could alter guidance for those with a 10 year risk of less than 10%. John Abramson and colleagues argue that statins have no overall health benefit in this population and that prescribing guidelines should not be broadened

Women and statin use: a women's health advocacy perspective.

This paper is based on a longer report on the benefits, safety and modalities of information representation with regard to women and statin use, situated within the historical context of Womens Health Movement which has advocated for unbiased, appropriate medical research and prescribing for women based on the goals of full-disclosure, informed consent, evidence-based medicine and gender-based analysis. The evidence base for prescribing statins for women, especially for primary prevention is weak, yet Canadian data suggest that half of all prescriptions are for women. Safety meta-analyses do not disaggregate for women; do not consider female vulnerability to statin induced muscle problems, and women-centred concerns such as breast-cancer, miscarriage or birth defects are under-researched. Many trials have not published their non-cardiac serious adverse event data. These factors suggest that the standards of full-disclosure, informed consent, evidence-based prescribing and gender-based analysis are not being met and women should proceed with caution.

The kitchen and the multinational corporation: An analysis of the links between the household and global corporations

The paper examines relationships between multinational corporations and the unwaged work women do in their homes. It is argued that far from being a sanctuary, the home has become a dumpsite for unnecessary and unsafe products. Women in North America and the Third World are now dealing with health and safety issues in their neighbourhoods and households. Consciousness of these dangers has resulted in mobilization and the formation of alliances aimed at confronting multinationals and securing more government regulation. The experience of one group of women in a small Ontario community is described.

Remediating “Lessons from the controversy over statins”

1 Armitage J, Baigent C, Collins R. Lessons from the controversy over statins—Authors’ reply. Lancet 2016; 388: 2237–38. 2 Horton R. Lessons from the controversy over statins—Editor’s reply. Lancet 2016; 388: 2237. 3 Krumholz HM. Statins evidence: when answers also raise questions. BMJ 2016; 354: i4963. 4 Redberg RF, Katz MH. Statins for primary prevention: the debate is intense but the data are weak. JAMA Intern Med 2017; 177: 21–23. 5 Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532–61. 6 Godlee F. Statins: we need an independent review. BMJ 2016; 354: i4992. 7 Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 2014; 348: g2545. 8 Deer B. How the case against the MMR vaccine was fixed. BMJ 2011; 342: c5347. 9 Abramson J, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ 2013; 347: f6123. 10 Deer B. Secrets of the MMR scare. The Lancet’s two days to bury bad news. BMJ 2011; 342: c7001. herself from handling a complaint against The BMJ was in part due to a change in personnel at The BMJ, which created a conflict of interest partway through the process. COPE investigated the complaint to the full extent of its remit, more quickly than reported in The Lancet, and with due care to ensure independence. COPE’s conclusion was emphatic: that The BMJ had taken “extraordinary steps” and “acted appropriately by completing an internal investigation and audit to a high standard, and promoted transparency by making information on the process publicly available”. Comparisons between the statin saga and the measles, mumps, and rubella vaccine scare also do not serve Horton or Collins well. The BMJ’s article in question was not a poorly done and fraudulent piece of research but an expert reanalysis and commentary; after it was published it was not the journal or the authors but Collins who launched the media scare when he went to the press despite repeated invitations to air his concerns in The BMJ. The BMJ did not attempt to cover up concerns, leading to years of delay, but corrected the article within months and referred the decision about retraction to a panel of experts. Retraction Watch called the panel’s report “the most detailed justification for a journal’s decision not to retract a paper that we’ve seen in a long time, perhaps ever”. I fully support efforts to ensure that everyone involved in creating and publishing medical knowledge can be held accountable. I also support proposals for a radical rethink about how the evidence base is built and used. In this effort, the lessons learnt by all parties involved in the statins saga could play an important part.

Authors’ reply to Huffman and colleagues

We thank the Cochrane review authors for their thoughtful comments (highlighted in quotes below), which give us the opportunity to clarify unresolved issues about the benefits and harms of statins in low risk people.1 > “This article predated by three weeks the publication of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol treatment guidelines (12 November 2013), but statements were made about ‘proposed standards’ without full knowledge of these guidelines.” The “proposed standards” that we referred to in our article were not the yet to be published 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on cholesterol treatment.2 3 Rather, they were the 2013 update of the Cochrane review on statins for the primary prevention of cardiovascular disease,4 which had incorporated the findings and recommendations of the 2012 Cholesterol Treatment Trialists’ (CTT) meta-analysis.5 The 2012 CTT meta-analysis reported that statins significantly reduce major vascular events in people “with 5-year risk of major vascular events lower than 10%.” It concluded that the current major guidelines—ATP-III in the US, the European Society of Cardiology task force, and the National Institute for Health and Care Excellence guidelines in the UK—“might need to be reconsidered.” The 2013 Cochrane review stated: “in light of new evidence derived from the CTT Collaboration on primary prevention, there is a need to update existing cost-effective analysis.” We based our comments about “proposed standards” on these calls to update existing recommendations. Although we had no advanced knowledge of the contents of the forthcoming ACC/AHA cholesterol treatment guidelines, we anticipated that these findings and recommendations would be influential. > “Abramson and colleagues state: ‘Under the proposed 2013 standards, however, no level of risk would preclude statin therapy’” The 2012 CTT meta-analysis concluded: “The present report shows that statins are indeed both effective and safe for …

Safety and efficacy of statins

www.thelancet.com Vol 389 March 18, 2017 1097 reduction in LDL for 5 years would avoid 15 major vascular events per 1 000 people in the 5% to 10% risk category (ie, 1·5% absolute benefit). Furthermore, a third of these events were revascularisation procedures, so the absolute risk reduction in so-called hard events (ie, heart attacks and strokes) is 100 per 10 000 patients, or 1%. In other words, the 2012 CTT metaanalysis shows that 100 patients in this risk category would have to be treated for 5 years to prevent one heart attack or stroke. Thus, the real benefit shown by the CTT data is 80% lower than that claimed by Collins and colleagues. Finally, the Review cites our 2013 BMJ paper, but fails to report our primary research finding—that statin therapy does not significantly reduce all-cause mortality (the CTT primary outcome) for patients with less than 10% 5-year risk of cardiovascular disease. This result was upheld by two independent statistical reviews as part of the expert panel review that adjudicated Collins’ (unanimously rejected) demand for retraction of our paper. Omission of this crucial finding is misleading.

Regulatory data are hidden in plain sight

The editorial by Doshi and Godlee rightly argues for better communication among regulatory scientists, medical journals, and the public, especially when evidence held by regulators differs from journal publications.1 Watchdog groups, such as the health reform group of Public Citizen, routinely access material posted online by the US Food and Drug Administration, but …

Authors’ reply to Davis and Dietrich

Davis and Dietrich raise important concerns about our analysis of the effect of statins in people at low risk of cardiovascular disease.1 2 On the basis of Cholesterol Treatment Trialists’ (CTT) data published in 2012,3 we showed that statins do not reduce overall mortality in people with less than a 20% 10 year risk of a major vascular event. Davis and Dietrich are correct that all cause mortality was significantly reduced in patients treated with rosuvastatin compared with controls in the JUPITER trial.4 However, the data from this study were included in the CTT meta-analysis of 2012, so singling out the all cause mortality findings from this study alone would undermine the purpose of the meta-analysis. That said, other aspects of the JUPITER trial merit consideration. At the time that the study was prematurely stopped, the number of deaths from cardiovascular causes (myocardial infarction and …

Statin therapy in women: Concerns and caution

Abstract There is a growing body of literature interrogating statin therapy for women, particularly in the primary prevention of coronary heart disease. Several meta-analyses have found little evidence of benefit for this population. Ongoing analytical impediments have been described regarding the continued failure of investigators to release relevant data. In the secondary prevention of coronary heart disease in women, statin therapy has been found to decrease coronary heart disease events and mortality, but not all-cause mortality. There is evidence based concern over statin therapy in increasing cancer incidence and mortality in women. Issues regarding the estimation of benefit, aggressive marketing, data disclosure and insufficient attention to adverse events need to be addressed.